I-CBT Tailored to Patients With Cardiovascular Disease and Insomnia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-02-01

Brief Summary

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The Hit-IT study is based on an internet-based cognitive behavioral therapy program tailored to patients with different types of cardiovascular diseases and insomnia. A randomized controlled trial design is used. A 9 weeks internet-based cognitive behavioral therapy intervention vs a 3 weeks sleep hygiene education.

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Detailed Description

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DESIGN: Randomized controlled trial with 1-year follow-up. All patients with cardiovascular disease (i.e., myocardial infarction, heart failure, atrial fibrillation and angina) from 4 primary care centers will be screened for insomnia and during a clinical examination diagnosed by a physician specialized in sleep medicine. INTERVENTION: 9 weeks internet-based cognitive behavioral therapy for insomnia (1 week introduction, 2 weeks psycho education on cardiovascular disease/insomnia, 6 weeks of sleep hygiene, stimulus control and sleep restriction) vs 3 weeks internet-based sleep hygiene education. QUESTIONNAIRES: Sleep (Pittsburgh Sleep Quality Index, Insomnia Severity Index, sleep diary), depressive- and cardiac symptoms (Patient Health Questionnaire-9, Cardiac Anxiety Questionnaire) and Quality of Life (SF-12) at baseline, during and after intervention (after 6 and 12 months).

Conditions

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Insomnia Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial. The intervention group participated in a nine-week internet-based cognitive behavioral therapy program. The initial parts of the program, focusing on cardiovascular disease was initially tailored to fit patients with heart failure and has undergone pilot testing. The intervention program used in the current study was adapted to fit also patient with other cardiovascular diagnoses (i.e., heart failure, myocardial infarction, atrial fibrillation) and comprise 1-week of introduction, 2 weeks psycho education on cardiovascular diseases/insomnia, 6 weeks of sleep hygiene, stimulus control and sleep restriction. The Control Group receive 3 weeks of internet-based sleep hygiene education.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Single blinded (PI). The randomization is performed by a study team member who was blinded to screening and baseline data. The physician who assessed the patients had access to them in a random sequence. Patients were randomized 1.1 to nine-week internet-based cognitive behavioral therapy (intervention group) or online 3 weeks sleep hygiene (control group) generated by an independent researcher using a block size of two. Masking of patients was not possible since the interventions is a internet-based cognitive behavioral therapy program. Outcome measures were not necessary to mask since these were automatically collected via the study platform.

Study Groups

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I-CBT

Internet-based cognitive behavioral therapy program including 1-week introduction, 2 weeks psycho education on Cardiovascular disease/insomnia, 6 weeks of sleep hygiene, stimulus control and sleep restriction

Group Type EXPERIMENTAL

Internet-based cognitive behavioral therapy for insomnia

Intervention Type BEHAVIORAL

Patients will be provided with psycho education on different cardiovascular diseases, sleep, insomnia, and provided with different behavioral techniques to improve their sleep. The participants in the intervention Group who receives the Internet-based cognitive behavioral therapy program will also have access to support given by a nurse specialized in sleep. A module is given each week during the 9-week intervention.

Control group

3 weeks internet-based sleep hygiene education

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

Control group receiving 3 weeks internet-based education on sleep hygiene. A module is given each week during the 3 weeks.

Interventions

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Internet-based cognitive behavioral therapy for insomnia

Patients will be provided with psycho education on different cardiovascular diseases, sleep, insomnia, and provided with different behavioral techniques to improve their sleep. The participants in the intervention Group who receives the Internet-based cognitive behavioral therapy program will also have access to support given by a nurse specialized in sleep. A module is given each week during the 9-week intervention.

Intervention Type BEHAVIORAL

Control group

Control group receiving 3 weeks internet-based education on sleep hygiene. A module is given each week during the 3 weeks.

Intervention Type OTHER

Other Intervention Names

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Internet-based CBT

Eligibility Criteria

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Inclusion Criteria

* age over 18 years
* having a clinical diagnose of insomnia
* being treated for heart failure, coronary artery disease or atrial fibrillation
* access to a computer with an Internet connection, access to a mobile phone and was willing to participate in a treatment for their insomnia.

Exclusion Criteria

* no access to internet, computer or cellphone.
* not understanding the Swedish language
* suffering from cognitive disabilities, severe psychiatric disease, severe somatic disease or sleep apnea
* suffering from drug abuse
* been hospitalised for heart failure, coronary artery disease or atrial fibrillation in the last four weeks
* expected survival less than 12 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No